After months of public debate and criticism over secrecy, Health Canada shared its first public drug review on Tuesday: a brief summary of a controversial acne pill linked to 13 deaths of young women, which raises more questions than it answers.

The 10-paragraph synopsis on Diane-35 is supposed to shed light on the data Health Canada considered when it concluded that the medication’s benefits outweigh its risks. But a prominent drug safety researcher called the assessment “highly problematic” and “quite limited” in scope.

“The summary really does not provide any detailed information on effectiveness or safety that would help prescribers or patients make a decision about whether to use this medicine,” said Barbara Mintzes, an assistant professor at University of British Columbia who has investigated the widespread, off-label use of Diane-35 for birth control.

About 40,000 Canadian women are on the pill, which is approved for use only for patients with what is considered otherwise untreatable acne, Health Canada reported.

A Toronto Star investigation into Diane-35 and the sudden death of Calgary teenager Marit McKenzie last January triggered the unprecedented public release of federal drug safety reviews.

The Canada Vigilance database, a voluntary reporting system that tracks drug-related side effects, as of May 2013 included 12 fatalities of young women whose deaths were suspected of being caused by Diane-35.

Two of these cases, however, according to the summary report released on Tuesday, did not contain enough detail to confirm a “possible” correlation with the drug.

McKenzie’s death is the 13th, Health Canada officials confirmed. Though her case was reported to the federal database by a hospital pharmacist and her family shortly after her sudden death on Jan. 28, 2013, it did not appear in the computer system until after Health Canada concluded its review and is not reflected in the review.

The first-year University of Calgary student died of complications from a massive blood clot two days before France suspended sales of the drug. The drug was re-introduced in January of this year after a review by Europe’s health regulator, though France voted against the move.

For months, the Star and McKenzie’s family pressed Health Canada for access to its safety review of Diane-35, which concluded the drug’s benefits outweighed its risks. Health Canada refused, citing “confidential business information,” until newly appointed Health Minister Rona Ambrose stepped in last October, four days after the first article was published.

“Greater access to easy to understand and credible information about the potential risks and appropriate use of health products is one of the most valuable safety tools we can provide Canadians and healthcare professionals,” Ambrose said on Tuesday in a written statement.

Mintzes says the summary report, while easy to read, falls well short of providing important data.

“Generally the report fails to address the question of whether this drug is providing any substantial advantages to health that outweighs the additional potential for harm, as compared to low-risk oral contraceptives or other alternatives for acne,” Mintzes said.

“It is mainly providing a rationale for the decision not to withdraw it from the market based on two things: the risks having been a concern for a long time rather than being a new problem; and the existence of other birth control pills that also have a poor safety profile in terms of risks of blood clots. However, these are not even named, so it doesn’t allow the prescriber or the patient to know which pill is lower risk, which to avoid.”

Full review reports are available upon request to Health Canada’s Marketed Health Products Directorate. These reports are subject to redactions of personal and confidential information, Health Canada said. The Star requested a copy on Tuesday and is awaiting a response.

Mintzes questioned why the report seems to examine only the drug’s risk of blood clotting rather than the full body of evidence on serious harmful effects that have been noted in pre-market clinical trials, observational studies and adverse event case reports.

When Diane-35 was being considered for marketing in Canada and was at first rejected, the main safety concern was the potential for one of the drug’s key ingredients to cause liver cancer, Mintzes said.

In the United Kingdom, the drug’s label includes a warning about depression and other psychiatric side effects.

It is not sold in the United States. Mintzes said reviewers should have consulted the Food and Drug Administration in the United States to ask whether the company that makes the drug, now Bayer Inc., applied for approval to market the drug and, if it was refused, on what grounds.

It’s unknown whether Health Canada investigators took this step.

Health Canada won’t say how many drug safety review summaries it plans to post, or how often. What is known is that the release of Diane-35 is likely an anomaly as the department told the Star it has no further plans to publish reviews that were completed prior to 2014.

“The plan is not to go retrospectively to publish reviews that we have (done),” said Dr. Supriya Sharma, a senior medical adviser with Health Canada.

Bruce McKenzie takes some comfort in the fact that there is now a little more public information about the drug suspected of killing his 18-year-old daughter, but it’s not enough, he said.

“Health Canada is basically patting itself on the back, saying we’ve done a great job, but the bottom line remains: How does information about serious side effects get to the public? Where is the connect between what the pharmacies publish when they dispense medications and what Health Canada says?”

McKenzie is referring to the fact that not all pharmacies warn patients equally about drug risks in the drug safety pamphlets they hand out.

While many major pharmacies highlight the “very serious” and “sometimes fatal” risk of blood clotting connected with Diane-35 on the drug information sheets they supply to patients, Shoppers Drug Mart does not. Instead, it advises patrons, his daughter included, to watch out for less-serious risks of headaches, tender breasts, menstrual pain, swelling and a lowered sex drive

NDP health critic Libby Davies called Ambrose’s new transparency initiative “a mini-step of progress” that fails to measure up to the minister’s promise of “complete change” in the way Health Canada does business.

“All of the information should be readily available,” Davies said. “You shouldn’t have to ask for it. Canadians have a right to know.”

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